Donawa Lifescience Consulting (DLC) organised a well-attended one-day seminar at the Michealangelo Hotel in Milan, Italy, on 23 January 2019, covering topics related to the new European regulations on medical devices (MDR, 2017/745) and in vitro diagnostics (IVDR, 2017/746), which come into full effect in May 2020 and May 2022 respectively.
The morning session covered the key changes from the In Vitro Diagnstics Directive to the IVDR, and their impact on IVD manufacturers and distributors. The seminar was given by Carlo d'Alessandro, DLC's Director, Quality and Regulatory. Carlo is DLC's expert in all things related to IVDs, having spent 13 years working in the sector before joining DLC in 2011 to provide clients with support on European and US IVD regulatory and performance evaluation issues.
The afternoon session covered the topic of how the new regulations affected clinical investigations, including their authorisation by ethics committees and competent authorities, study documentation, study conduct, monitoring, and event reporting. The presentation was given by Daniela Karrer, DLC' VP Operations and Clinical Affairs. Daniela is now in her tenth year managing DLC's CRO business, having previously managed the Southern Europe office for a major CRO, allowing clients to benefit from her extensive experience in managing clinical studies.